Tag:

Regulation

Dodging Pitfalls on the Path to Success: Data Management Risks and How to Mitigate them

Every day, thousands of gigabytes of data flow around the world. Transfers between consumers and producers make up a large portion of that data. There has been talk recently of the commercialization of said data, such as Facebook and Google selling their users’ data to third parties. These third parties are more than willing to pay large sums for this information, as it provides actionable data on consumer trends, such as their likes and dislikes. This data can be used by companies to shift their marketing strategies to capture a greater market share. For the e-commerce retailer, whether large or small, this data can be valuable as a resource and a commodity. As such, knowing what you can and can not do with the data is important. Here, we will be discussing Data Management risks when it comes to the collection of consumer data.

Following Classification of Cryptocurrencies as Commodities, Regulators Shift Focus

On March 6th, 2018 the. District Court for the Eastern District of New York upheld the classification of cryptocurrencies, such as Bitcoin and Litecoin, as commodities. The ruling subjects the cryptocurrencies to the regulation of the U.S. Commodity Futures Trading Commission (CFTC).

Can Congress Regulate Big Pharma?

Drug companies need to fund the research and development necessary to create better products. This means that pharmaceutical companies have fought for years to maintain control over the prices of said drugs. But this standard is being challenged with a new bill that was introduced to the House of Representatives on June 25, 2018.

Kicking Off the 2018-2019 Academic Year at the Center for Compliance Studies

Ryan Meade Editor-in-Chief Director, Regulatory Compliance Studies at Loyola University Chicago School of Law The academic year for 2018-2019 has kicked off at the Center for Compliance Studies. It promises to be a big year with even more robust blog activity planned, a symposium in February 2019 that will be one of the first academic looks …
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FDA Faces Forward with Flexible Genetic Guidance

In recent years, the FDA has examined a record number of revolutionary medical devices, many of which have been genetic tests. Genetics has taken the world by storm. The medical world continues to look toward genetics as a promising next step in revolutionizing treatment, while the American public has shown a growing interest in learning more about themselves through services like Ancestry and 23andMe. In an effort to gain a foothold on the rapidly developing field of technology, the FDA has recently made efforts to modernize its approach by issuing new guidance to ensure the validity of these tests.

The Food Safety Modernization Act is Just the Beginning of the FDA Compliance We’ve Been Waiting For

Despite the United States having one of the safest food supplies in the world, more than 48 million Americans get sick from foodborne illnesses and diseases each year, and more than 128,000 are hospitalized and 3,000 die from similar issues that are largely preventable. On January 04, 2011 President Obama signed the Food Safety Modernization Act (“FSMA”) into law. This enactment was called the “most sweeping reform” of U.S. Food Safety laws in more than seventy years. But seven years later, the act is still only partially enforced as the FDA has faced resistance from the government as well as a lack of funding. The FMSA was and is intended to enable the FDA to protect the health of the public by strengthening the food system in the United States. While change and reform in the industry are necessary, what good are new reforms if they will not be enforced for years to come?

Digital Realty Trust: Implications for Whistleblowers and the Compliance Department

In a 9-0 decision, the Supreme Court on February 22, 2018 decided Digital Realty Trust, Inc. v. Paul Somers, a case challenging the definition of a whistleblower under the Dodd-Frank Wall Street Reform and Consumer Protection Act, commonly referred to as Dodd-Frank. The court held that “Dodd-Frank’s anti-retaliation provision does not extend to an individual, like Somers, who has not reported a violation of the securities laws to the SEC [Securities and Exchange Commission].” This is a narrowing of the definition of whistleblower and as such has a number of implications for companies and their compliance departments.

TAX TALK SERIES: IRS Clarifies Post-TCJA Confusion on Home Equity Interest

On December 20, 2017, Congress passed the Tax Cuts and Jobs Act (“TCJA”) designed to decrease the taxable rate for corporations and individuals, and significantly limited allowable deductions. Since this change to the Tax Code was one of the largest since the Reagan era, the Internal Revenue Service will need to publish many regulations and advisories in the coming months to better clarify provisions of the TCJA. This multi-part series will explore prominent IRS regulations and advisories as they relate to the TCJA, and what these regulations and advisories mean for both individual and corporate taxpayers. 

U.S. Passports to be Revoked for Unpaid Taxes

Beginning January, 2018, U.S. citizens with unpaid taxes may find their U.S. passport applications denied and their existing passports revoked. The I.R.S. announced that it will begin implementation of procedures to notify the State Department of taxpayers the I.R.S. certifies as owing a “seriously delinquent tax debt.” This may come as a rude awakening to many Americans, although both the press and television news issued warnings going back more than a year ago. 

Trump Administration Creates New Division of Health and Human Services

The Trump administration has established a new division within the Department of Health and Human Services (HHS) called the Conscience and Religious Freedom Division. The stated purpose of this office is to “restore federal enforcement of our nation’s laws that protect the fundamental and unalienable rights of conscience and religious freedom.”

One day after the creation of this division, HHS proposed a new rule, providing further protections to healthcare workers who object to providing certain types of care to patients—including elective sterilization, gender reassignment surgery, or emergency contraception—based on their personal religious beliefs. Additionally, the Trump administration issued a new directive, reversing an Obama administration directive which prohibited states from refusing to send federal funds to qualified providers. This new division, new rule, and new directive serve to ensure the already-existing rights of physicians, nurses, and healthcare staff at the expense of their patients.